Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT01176032
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2010-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
The "ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)" Study
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLMARK
Brief Summary:
The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.
Detailed Description:
Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (\<140/90 mmHg).
The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (\<140/90 mmHg), the dose of amlodipine was increased to 10 mg.
Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (\<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed
The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (\<140/90 mmHg), the dose of amlodipine was increased to 10 mg.
Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (\<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-016735-36 | EUDRACT_NUMBER | None | View |